Using Shenfu Injection to Protect Heart Function in Septic Shock
Official title: The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis: a Multicenter, Randomized Controlled Study
Run by First Affiliated Hospital of Wannan Medical College · NCT06898723 · Data updated 2026-11-12
This study tests if adding Shenfu Injection to regular treatment can help people with septic shock keep their hearts working better and recover faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 440 (estimated) |
| Sponsor | First Affiliated Hospital of Wannan Medical College Academic / other |
| Locations | 1 site (Wuhu, Anhui) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | March 27, 2025 |
| Trial ID | NCT06898723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with septic shock.
✕Probably not a fit
Patients with severe underlying diseases or recent severe cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of Shenfu Injection, a traditional Chinese medicine, in preventing heart dysfunction in patients experiencing septic shock. The study aims to determine if adding this injection to standard treatment can enhance cardiac function, accelerate recovery, and improve survival rates. It is a multicenter, randomized controlled trial comparing outcomes between patients receiving standard care alone and those receiving standard care plus Shenfu Injection. The trial focuses on patients diagnosed with septic shock according to Sepsis 3.0 criteria.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and survival rates in patients suffering from septic shock.
How similar studies have gone: While traditional Chinese medicine approaches have been explored, the specific use of Shenfu Injection in this context is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0; * 2\. Age ≥ 18 years. Exclusion Criteria: * 1\. Pregnant or breastfeeding women; * 2\. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components; * 3\. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.; * 4\. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association \[NYHA\] Class IV); * 5\. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma; * 6\. Use of Ginseng and Aconite Injection for less than 48 hours; * 7\. Patients expected to die within 48 hours; * 8\. Patients deemed unsuitable for this study by the investigator.
Where it's running
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The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, China Recruiting
Study contacts
- Study coordinator: Qiancheng Xu
- Email: qianchengxu@wnmc.edu.cn
- Phone: 86-18297529106
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone
In septic shock, this trial tests whether adding fludrocortisone (50 mcg or 100 mcg daily) to hydrocortisone improves survival and recovery compared with placebo.
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Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
-
Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter
This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.
-
Personalized Fluid Resuscitation in the Emergency Department
This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.
-
Discordance between capillary refill time and oxygen use in septic shock
This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
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Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock
This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.